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Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia

NCT ID: NCT05070845

Last Updated: 2026-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-02

Study Completion Date

2027-10-01

Brief Summary

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This is a Phase 2, open-label, multicenter, multiple subcutaneous injection, safety and efficacy study of PF-06835375 in adult participants with primary immune thrombocytopenia (ITP). This study will focus on participants with persistent (\>3 months and ≤12 months), or chronic (\>12 months) ITP

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Detailed Description

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This study is designed to elucidate the effects of PF-06835375 on platelet counts in participants with moderate to severe primary ITP. Based on the experience with other B-cells depleting agents, it is expected that the platelet counts will increase following a standard treatment. Each participant in cohort 1 will receive 1 subcutaneous injection of dose 1 every month for 3 months during the 12-week treatment period. And each participant in cohorts 2 and 3 will receive 1 subcutaneous injection of dose 2 or 3 every month for 4 months during the 16-week treatment period. This should provide sufficient levels of exposure and depletion of CXCR5 positive cells to sustain the effects of PF-06835375 during the treatment period. Additional depletion of Tfh cells may provide sustained increase in platelet count following the last treatment.

Conditions

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Primary Immune Thrombocytopenia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

open label

Study Groups

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Open Label PF-06835375 dose 1 Treatment

subcutaneous injection once monthly for 3 months

Group Type EXPERIMENTAL

PF-06835375

Intervention Type BIOLOGICAL

CXCR5 inhibitor

Open Label PF-06835375 dose 2 Treatment

subcutaneous injection once monthly for 4 months

Group Type EXPERIMENTAL

PF-06835375

Intervention Type BIOLOGICAL

CXCR5 inhibitor

Open Label PF-06835375 dose 3 Treatment

subcutaneous injection once monthly for 4 months

Group Type EXPERIMENTAL

PF-06835375

Intervention Type BIOLOGICAL

CXCR5 inhibitor

Interventions

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PF-06835375

CXCR5 inhibitor

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Primary ITP. Ongoing ITP (platelet counts \<50 x 109/L) \[No severe bleeding within 1 month or during screening\] AND Persistent ITP (3 to 12 months) or Chronic ITP \>12 months

Exclusion Criteria

* Bleeding event according to the WHO grading scale ≥2 occurring ≤4 weeks prior to screen OR a current bleeding event that, in the opinion of the investigator, requires treatment with standard of care therapy OR require blood or blood products during screening
* Splenectomy within 3 months of randomization or planned during the study duration.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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East Carolina University

Greenville, North Carolina, United States

Site Status RECRUITING

South West Radiology

Liverpool, New South Wales, Australia

Site Status RECRUITING

Slade Pharmacy

Mount Kuring-Gai, New South Wales, Australia

Site Status RECRUITING

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Site Status RECRUITING

ICON Cancer Centre - Kurralta Park

Kurralta Park, South Australia, Australia

Site Status RECRUITING

The Alfred Hospital

Melbourne, Victoria, Australia

Site Status RECRUITING

Royal Perth Hospital

Perth, Western Australia, Australia

Site Status RECRUITING

Unity Health Toronto, St. Michael's Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

McGill University Health Centre

Montreal, Quebec, Canada

Site Status RECRUITING

Fakultni nemocnice Hradec Kralove

Hradec Králové, , Czechia

Site Status RECRUITING

Vseobecna fakultni nemocnice v Praze

Prague, , Czechia

Site Status RECRUITING

Pécsi Tudományegyetem Klinikai Központ

Pécs, Baranya, Hungary

Site Status ACTIVE_NOT_RECRUITING

Somogy Megyei Kaposi Mór Oktató Kórház

Kaposvár, Somogy County, Hungary

Site Status RECRUITING

Semmelweis University

Budapest, , Hungary

Site Status RECRUITING

Petz Aladár Egyetemi Oktató Kórház

Győr, , Hungary

Site Status RECRUITING

Komárom-Esztergom Vármegyei Szent Borbála Kórház

Tatabánya, , Hungary

Site Status NOT_YET_RECRUITING

AIDPORT Sp. z o.o.

Skórzewo, Greater Poland Voivodeship, Poland

Site Status RECRUITING

InterHem

Bialystok, , Poland

Site Status ACTIVE_NOT_RECRUITING

Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne

Gdansk, , Poland

Site Status ACTIVE_NOT_RECRUITING

Pratia Onkologia Katowice

Katowice, , Poland

Site Status RECRUITING

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, , Poland

Site Status ACTIVE_NOT_RECRUITING

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

Wroclaw, , Poland

Site Status RECRUITING

Addenbrooke's Hospital

Cambridge, Cambridgeshire, United Kingdom

Site Status RECRUITING

Derriford Hospital

Plymouth, Devon, United Kingdom

Site Status RECRUITING

The Royal Cornwall Hospital

Truro, England, United Kingdom

Site Status RECRUITING

Hammersmith Hospital

London, , United Kingdom

Site Status RECRUITING

Countries

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United States Australia Canada Czechia Hungary Poland United Kingdom

Central Contacts

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Pfizer CT.gov Call Center

Role: CONTACT

[email protected]
1-800-718-1021

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C1131003

To obtain contact information for a study center near you, click here.

Other Identifiers

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2023-509338-21-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

C1131003

Identifier Type: -

Identifier Source: org_study_id

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